Trials / Completed
CompletedNCT00558012
Zoledronic Acid for Osteoporosis in the Elderly
Maintenance of Skeletal Integrity in Frail Elders
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
This trial will examine the safety, efficacy and feasibility of a single dose of intravenous zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women, who are most at risk for the deleterious outcomes of osteoporosis. The investigators will test the hypothesis that in institutionalized elderly women a single dose of intravenous zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3) provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in planning a future study.
Detailed description
This is a 2-year, randomized, double-blind, calcium/vitamin D-controlled clinical trial of a single dose of therapy with at least 12 months follow-up. All participants will receive calcium and vitamin D throughout the trial. At baseline, 190 women will be randomized in a 1:1 allocation to zoledronic acid (group 1) or zoledronic acid placebo (group 2). At the end of 24 months, women will be followed to gather data on longer term fragility fracture rates and survival until all participants have completed 24 months of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravenous zoledronic acid | Intravenous zoledronic acid 5.0 mg once |
| DIETARY_SUPPLEMENT | Vitamin D 800 IU/daily | Daily divided dose |
| DIETARY_SUPPLEMENT | Calcium 1200 mg/daily | supplement plus diet |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2007-11-14
- Last updated
- 2015-07-31
- Results posted
- 2015-07-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00558012. Inclusion in this directory is not an endorsement.